Pregabalin may increase the risk of major birth defects in babies if used by women during pregnancy, a study has suggested, prompting the Government to issue new guidance

The use of pregabalin during the first trimester of pregnancy has been associated with malformations in babies to the nervous system, eye, face, urinary system, and genitals.

Pregabalin is a medication that has increasingly been prescribed to treat chronic pain, however, it is also used to treat epilepsy, fibromyalgia, restless leg syndrome, and generalised anxiety disorder.

Following a review of the large nordic study, the Government updated its stance on the drug and told healthcare professionals not to prescribe pregabalin during pregnancy.

The guidance, published yesterday (19 April), stated the drug should not be used ‘unless clearly necessary and only if the benefit to the patient clearly outweighs the potential risk to the foetus'.

Healthcare professionals must also continue to provide counselling to patients using pregabalin on the potential risks to an unborn baby, it added.

They also must advise patients planning a pregnancy or who become pregnant during treatment to make an appointment to discuss their health condition and any medicines they are taking.

The use of pregabalin during pregnancy has been associated with an increased risk to the foetus since last year, following a national review into the safety of antiepileptic drugs in pregnancy.

However, due to conflicting data, no firm conclusions could be drawn on the potential teratogenic effect of pregabalin, the MHRA said.

The recent research, which the MHRA said produced ‘fuller data’ on the risks of pregabalin involved the study of more than 2,700 pregnant women exposed to pregabalin.

It found that the rate of deformities in babies, whose mothers took the drug during their first trimester, was 5.6%.

Meanwhile, only 4.1% of babies whose mothers did not use the drug or any other anti-epileptic medication were born with deformities.

This comes after The Sunday Times revealed that sodium valproate has been given to women in the UK for years without proper warnings causing autism, learning difficulties and physical deformities in up to potentially 20,000 babies in Britain.

Last year, the MHRA confirmed with the Pharmacists’ sister publication, Pulse, that it did not plan to take regulatory action on pregabalin prescribing by GPs.

GPs in Northern Ireland were told they should no longer initiate prescriptions of pregabalin for neuropathic pain following a ‘significant increase’ in deaths related to the drug.

In February 2022 the regulator said that pregabalin may be associated with serious breathing problems in patients with compromised respiratory systems.

Back in 2019, pregabalin was reclassified as a class C drug following a rise in the number of deaths linked to the drug.